Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women

Phase 3

• Conditions: Neonatal Mortality; Low Birth Weight; Anemia

• Registration Number: NCT00148629
• Lead Sponsor: Cornell University

Brief Summary

The purpose of this research is to compare the efficacy of two low-cost low intervention packages to prevent and treat severe anemia in pregnant women in Zanzibar, Tanzania. The two packages are Standard of Care as described by the WHO (presumptive treatment for malaria and helminths plus daily iron + folic acid supplements) and Enhanced Care (Standard of Care plus daily multivitamins and a 2nd dose of anthelminthic.)

Detailed Description

This is a clinic-randomized trial involving 8 antenatal clinics and approximately 2500 women. The specific aims are:

Aim 1: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the prevention of severe anemia among pregnant Zanzibari women. This aim will be achieved through a pre-post intervention comparison.

Aim 2: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant Zanzibari women.

Aim 3: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the cure of severe anemia among pregnant Zanzibari women.

Aim 4: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant Zanzibari women.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2500

Inclusion Criteria

• Pregnant woman

Exclusion Criteria

• Not a permanent resident of the community

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of severe anemia (Hb < 7 g/dL)
Cure of severe anemia

Secondary Outcome Measures

Name	Time	Method
Infant birth weight
Neonatal mortality
Neonatal morbidity
Blood loss during delivery

Trial Locations

Locations (1)

Public Health Laboratory "Ivo de Carneri"; 🇹🇿 Wawi, Zanzibar, Tanzania